(567ab) A Fast Development for a High Titer Manufacturing Process

Monoclonal antibodies (mAB) have become a major class of proteins for human therapeutic use. An efficient manufacturing process is desired to meet the increased demand for the therapeutic doses. Over the past several years, cell culture process platforms based on chemically-define media have been developed, implemented, and improved to enable fast track from development to manufacturing, increased process consistency as well as to lower supply chain risk from raw materials manufacturers . This poster highlights a significant milestone recently achieved at Biogen Idec on the successful completion of the first >5 g/L process in GMP Manufacturing. Within 3 months, this manufacturing process was developed based on the existing chemically-defined platform. The strategies of adjusting nutrient feed volume and timing and extending cell culture duration were employed to reach high final titer. The rapid development of such highly productive process platforms translates to increased manufacturing facility efficiency and flexibility as well as significant resource and cost savings.